Events
Duane Morris Special Counsel Michael Swit to Explore "FDASIA—Challenges and Opportunities for Drug and Device Companies"
April 16, 2013 | Webinar
Duane Morris special counsel Michael Swit will lead a webinar on "FDASIA—Challenges and Opportunities for Drug and Device Companies" on Tuesday, April 16, 2013.
In July 2012, in conjunction with reauthorizing user fees for drug and device applications at FDA, Congress enacted a number of other provisions as part of the Food and Drug Administration Innovation and Safety Act (FDASIA). While the user fee provisions of FDASIA are quite well-known, the 2012 law impacted drug and device companies in a number of ways that industry members should know in greater detail. Ranging from such issues as the creation of a "Breakthrough Therapies" program for pharmaceuticals and biologics, to streamlining the De Novo petition process for innovative devices, FDASIA created a number of new opportunities and also challenges for regulated industries.
This webinar will explore the key provisions impacting drug and device companies and how they both benefit and burden those industries. Anyone involved in regulated drug or device companies should be aware of these challenges and benefits so they can properly position their companies to respond appropriately. In addition to reviewing the key drug and device provisions of FDASIA (other than user fees), Mr. Swit will explore the impact of the election of a second term for President Obama on FDA's regulatory authority, as well as the impact of sequestration. Finally, several key recent changes in the FDA organizational authority will be reviewed for their impact on regulated industry.
For more information, or to register please visit the Compliance2go website.
